DEVICE: GUM® (00070942007849)
Device Identifier (DI) Information
GUM®
KIT59
In Commercial Distribution
SUNSTAR AMERICAS, INC.
KIT59
In Commercial Distribution
SUNSTAR AMERICAS, INC.
US Professional Dental Sample Kit comprised of
1 x 525PHS Deep Clean Technique Toothbrush
1x 2030PQA Expanding Floss
1 x 828PQ Twisted Mint Flosser
1 x 872PQ Proxabrush Tight Interdental Brush
1 x 3612PQ Proxabrush Moderate Interdental Brush
1 x 650PA Soft Pick Advanced Interdental Pick
1 x 308PD End Tuft Toothbrush
1 x 600PYC Rubber Tip Stimulator
1 x 760PB Tongue Cleaner /Scraper
1 x 895 PQ Crayola Kids Flosser
1 x 227A Crayola Marker Toothbrush
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33208 | Periodontal pick/brush, reusable |
A manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device.
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Active | false |
31817 | Basic manual toothbrush |
An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.
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Active | false |
11158 | Dental floss |
A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused.
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Active | false |
42538 | Tongue scraper, reusable |
A device used to scrape the upper surface of the tongue to promote oral hygiene (e.g., to remove plaque, food debris, and bacteria, and to prevent bad breath). It is normally available [non-prescription] over-the-counter (OTC). It is typically made of copper (Cu) because of its biostatic properties (i.e., bacteria will not grow on its surface), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JES | Floss, Dental |
EFW | Toothbrush, Manual |
JET | Pick, Massaging |
LCN | Scraper, Tongue |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ddaae650-a939-4e38-8050-887fe26c4ac8
November 07, 2024
1
October 30, 2024
November 07, 2024
1
October 30, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined